Apparatus for gelatin coating caplets

ABSTRACT

A feeder device is provided for inserting solid medicaments, such as caplets, into a holding fixture for subsequent processing, for example, dipping in a gelatinous material. The feeder device incorporates a novel selector for eliminating partial pieces of medicaments before these pieces can be disposed into the holding fixture. The disclosed simple mechanical selection apparatus can eliminate these pieces efficiently prior to costly additional processing steps. Also included with this invention are novel mechanisms for regulating the flow of medicaments from a hopper to a plunger assembly, whereby a single medicament at a time can be inserted into a corresponding holding fixture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application of my co-pendingapplication, Ser. No. 016,914, filed Feb. 20, 1987, now U.S. Pat. No.4,820,524, entitled "GELATIN COATED CAPLETS AND PROCESS FOR MAKINGSAME", which is commonly assigned and which is also hereby incorporatedby reference.

FIELD OF THE INVENTION

This invention relates to coated medicaments and processes for providinggelatinous coverings for such medicaments. This invention is alsodirected to novel apparatus for producing such medicaments.

BACKGROUND OF THE INVENTION

Until recently, the pharmaceutical industry has relied upon emptygelatin capsules for the encapsulation of medicinal agents as a popularmethod for administering drugs. Hard capsules are not new. As early as1848 Murdock introduced the two-piece, hard gelatin capsule. Capsulesare tasteless, easily administered and easily filled eitherextemporaneously or in large quantities commercially. Many patients findit easier to swallow capsules than tablets, therefore preferring to takethis form whenever possible. This preference has prompted pharmaceuticalmanufacturers to market certain products in capsule form even thoughthey are also available in tablet form.

Empty gelatin capsules are typically made from gelatin-glycerin, puregelatin, starch or sugar gelatin, or other soluble gelatin combinations.See Remington's Practice of Pharmacy, Martin & Cook, 17th edition, pp.1625-1630, which is herein incorporated by reference. Capsules serve asadequate housings for powders, masses, liquids, pellets and oils andoffer improved palatability and convenience.

Generally, empty hard gelatin capsules are manufactured using automatedequipment. This equipment employs rows of stainless steel pins, mountedon bars or plates, which are dipped into a gelatin solution maintainedat a uniform temperature and fluidity. The pins are then withdrawn fromthe gelatin solution, are rotated and then inserted into drying kilnsthrough which a strong blast of filtered air with controlled humidity isforced. A crude capsule half is thus formed over each pin during drying.Each capsule half is then stripped, trimmed to uniform length, filledand joined to an appropriate mating half. Such hard capsule makingsystems are sold by Cherry-Burrell of Cedar Rapids, IA.

During most of this century, empty gelatin capsules were a populardosage form for prescription and over-the-counter (OTC) drugs. ***However, in the early 1980's there was an unexpected increase intampering with the contents of those capsules, resulting in severalwidely publicized deaths. This curtailed consumer demand for theseproducts, caused ubiquitous concern regarding safety among those in thepharmaceutical community, and idled much of the industry's hard capsulemaking equipment. Improved gelatin capsules and tamper-resistantpackaging were then developed, but were expensive to produce and werenot foolproof.

Once the threat of capsule tampering was recognized, many manufacturerswithdrew their capsule products from the market, often replacing themwith solid, oblong-shaped medicaments referred to commonly as caplets.Caplets are solid oblong tablets which are sometimes coated withmaterial such as cellulose. Typically, this coating is applied usingcoating-pan systems such as the "Vector-Freund Hi-Coaters, sold byVector Corporation, 675 44th Street, Marion, IA, or the GC-1000" sold byGlatt Air Techniques, 20 Spear Road, Ramsey, NJ.

A coating-pan system has a perforated pan or a drum which revolves in amanner similar to a standard clothes dryer. The system includes anair-atomization, spray gun which is inserted into the center of the drumfor spraying a fine mist of coating material. A batch of solidmedicaments or caplets is typically introduced into the cylindrical pan,wherein said batch is caused to tumble. The tumbling action tends tosmooth out some of the rough edges on the caplets prior to coating themwith organic or aqueous film solutions which may contain solidadditives. Coating pans generally produce consistent coating thicknessesand weights but are capable of providing only one color coating.Coatings produced by this method are often thin, offering poor coverageof medicament imperfections and rough edges not removed by the tumblingoperation. Unless time is taken to build up a thicker coat, defects onthe solid core result in a medicament that does not exhibit a pleasingappearance and may be perceived as being harder to swallow. Moreover,coating abrasion occurring during tumbling produces a surface finish onthese medicaments that fails to exhibit the shiny surface that consumersand those in the art have associated with ease of swallowability.Applicant has pan coated caplets with gelatin on an experimental basisand has measured coating thicknesses of only about 6 mils. Moreover,these pan coated gelatin caplets were not observed to be as shiny ascaplets coated by a dipping process.

Swallowability, the ability to pass through the fauces, pharynx andesophagus into the stomach, is dependent on the physical characteristicsof the medicament as well as psychological factors. See Stedman'sMedical Dictionary, Anderson Publishing Co., 5th edition, p. 377, whichpage is herein incorporated by reference. Physical characteristics, suchas medicament shape, size and surface finish, can be correlated withesophageal adherence and swallowability. With respect to psychologicalfactors, swallowing is normally volitional in adults, and muscularcontractions of the throat are understood to be under the control of theindividual at a subconscious level. See Stedman's, at 1377. Consumersurveys suggest that a shiny, capsule-like appearance has a specialappeal to users as being easier to swallow. In addition, surveysindicate that consumers perceive capsule products to be more effective,thereby adding a possible additional placebo factor to their actualeffectiveness.

Solid medicaments comprising gelatin in their coatings have been taughtin a number of patents and abstracts. J.A. Glassman, U.S. Pat. No.3,228,789, for instance, is directed to peroral capsules and tablets anda method for manufacturing same. Glassman discloses delayed release,compartmental medicaments with gelatin coatings, and includes treatmentsfor tablets or pellet coatings. The abstract of Japanese patent52-041213, assigned to Feund Industry Ltd., discloses a process forcoating tablets with a solution containing gelatin as a film-formingagent. The abstract of Japanese patent 69-027916, assigned to Sankyo Co.Ltd., is directed to gelatin coated tablets and a process for makingsame. The process of this patent includes feeding raw tablets atcontinuous intervals into a support. The tablets are immersed in acoating solution which can comprise gelatin. They are then recovered andheld on a holder. Excess coating solution deposited at the lower surfaceof the tablet is removed by an eliminating plate, and finally the tabletis released into a cooling solution from which it is recovered and driedto produce a seamless coated tablet. The abstract of Japanese patent65-009992,assigned to Konishi, is directed to a film-coating methodusing gelatin for coating tablets in a coating pan. The gelatindescribed in this abstract is pre-treated with water in apressure-cooker at a 120°-140° F. for 30-40 minutes to reduce theadhesive properties of the gelatin to allow coating of the tablet. Theabstract of Japanese patent 65-009994, also assigned to Konishi, isdirected to coating tablets in a coating pan with an emulsion includinga mixture of hot water, gelatin, a surface active agent and a memberselected from a group consisting of fats and oils, paraffin and wax. Theuse of the emulsion described in this patent abstract allows tablets tobe coated with gelatin in the same manner as coating tablets with sugar.See also the abstract of an article by Richardson entitled "FranciscusPill Coater", Phar. Hist., 28: 90-91 (2) 1986. This abstract is directedto the Franciscus Pill Coater, one of the later refinements of thegelatin-coated process that appealed to the practicing pharmacists inthe 19th century. Other abstracts also disclosing coatings for solidmedicaments comprising gelatin include those for: Japanese patent60-084215, assigned to Shinetsu Chemical Industries, U.S. Pat. No.4,238,510, assigned to Lifesavers, Inc., and Japanese patent 60-026677,assigned to Daiichi Seiyaku Co. Ltd.

Several patents have disclosed the concept of coating Pills by dippinghalf the surface of the pill at a time. Richards, U.S. Pat. No. 599,865is directed to a process and apparatus for dipping pills wherein anadhesive bearing bar is used to hold the pills before dipping them intogelatin. This process requires great care in maintaining the consistencyof the adhesive material, i.e. wax, so that each pill will adhere to thedipping-bar. The specification of Richards also warns that great caremust be taken not to dip the pills so deep as to get any of the gelatinupon the wax, which may ruin its adhesive capacity. The method ofRichards additionally is labor intensive, and therefore, is moreexpensive by today's standards. Clark, U.S. Pat. No. 724,436, isdirected to a pill coating machine that employs pill-bars having aseries of perforations for receiving pills. Each perforation is adaptedfor suction, whereby the pill is held in position during the dippingoperation. Banker, U.S. Pat. No. 3,896,762, discloses a rotary immersioncoating that similarly employs suction to hold solid medicaments priorto passing these medicaments through a coating bath. While Clark andBanker provide apparatus for holding and dipping medicaments, neitherdiscloses that the final product will exhibit a capsule-like appearancewith or without a seam. Moreover, applicant has tested vacuum holdingapparatus and has discovered that the suction tends to attract some ofthe gelatin into the holder, producing an irregular seam. Vacuum holdingsystems such as these also require significant power consumption, areoften complicated and uncertain in their action, and necessitateexpensive and sensitive vacuum equipment. Finally Oddo, U.S. Pat. No.3,045,641, discloses apparatus for color-coding tablets that utilizes arotating resilient roller impregnated with a coating substance, wherebytablets are passed beneath the roller on a conveyor and are deeplyimpressed into the resilient roller surface. This patent does notdisclose the use of gelatin or the use of a dipping process to produce athick capsule-like coating.

Although these gelatin coated medicaments and processes have achievedsome commercial success in the marketplace, a need remains for a coatedmedicament which is at least as tamper-resistant as a caplet whileproviding the ease of swallowability of a capsule. There is also a needfor a less expensive medicament coating method capable of producing amulti-colored, capsule-like coating which is perceived by the consumingpublic to be more effective.

SUMMARY OF THE INVENTION

The present invention provides a novel feeder device for inserting solidmedicaments into a holding fixture for facilitating the coating of thesemedicaments with gelatinous material. The device includes a hopper forcontaining the medicaments and insertion means for disposing at leastone of these medicaments into the holding fixture. A guide means is alsoprovided, having a medicament channel therethrough, for directing amedicament from the hopper into the insertion means. In an importantaspect of this invention, selection means are provided for eliminatingpartial pieces of medicaments before these pieces can be disposed intothe holding fixture. It is understood that these pieces can jamsubsequent mechanical operations and reduce the overall efficiency ofthe coating operation. The simple mechanical selection apparatusprovided by this invention can eliminate these pieces efficiently priorto costly additional processing steps. The savings associated with thisimproved feeder device can be reflected in lower cost medicaments forthe consumer. The feeder device greatly assists in the preparation ofgelatin-coated solid cores, such as caplets, and can be adapted forinserting a plurality of solid medicaments into a holding fixture forsubsequent coating applications.

Accordingly, an improved feeder device is provided for inserting solidmedicaments, such as the preferred caplets disclosed herein, into aspecially designed holding means. The device incorporates a novelmechanism for removing pieces of these caplets which may hampersubsequent processing steps. Also incorporated are novel guide means forpermitting the feeding of one caplet at a time, so that a caplet can beinserted to an appropriate depth in the holding means withoutinterference from other caplets. The feeder device is equipped withagitation means for facilitating a virtual constant flow of medicamentsinto dipping fixtures. Moreover, stopping and restraining rods aredisclosed for enabling "single medicament" loading into custom-designedholders.

It is, therefore, an object of this invention to provide a feeder devicewhich provides means for eliminating partial pieces of medicamentsbefore the pieces can be disposed into a holding fixture for subsequentprocessing.

It is another object of this invention to provide a feeder device thatprovides means for inserting a single solid medicament into a holdingfixture with little decrease in productivity.

It is another object of this invention to provide a feeder device thataccurately and efficiently inserts a caplet into a holding fixturewhereby an appropriate portion of the caplet is exposed for a subsequentcoating operation.

With these and other objects in view, which will become apparent to oneskilled in the art as the description proceeds, this invention residesin the novel construction, combination, arrangement of parts and methodssubstantially as hereinafter described and more particularly defined bythe attached claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate a complete embodiment of theinvention according to the best mode so far devised for the practicalapplication of the principles thereof, and in which:

FIG. 1 is a diagrammatic view of the a preferred manufacturing sequencefor providing a gelatin coating on caplets, illustrating how the capletsare inserted, how the gelatinous coating is applied to the first andsecond ends of the caplet, and how the caplets are dried and ejected;

FIG. 1A is a partial diagrammatic view of an alternative manufacturingsequence illustrating an alternative transferring method;

FIG. 1B is a partial diagrammatic view of an alternative manufacturingsequence illustrating an alternative holding means and transferringmethod;

FIG. 2 is an enlarged detail of a cross-sectional view of the holdingmeans 26 of FIG. 1 with a caplet being dipped in a gelatinous material,said caplet being retained by "O"-rings 100 and 102;

FIG. 3 is an enlarged detail of a transverse cross-sectional view of analternate holding means illustrating a flat spring 202:

FIG. 4 is an enlarged detail of a longitudinal cross-sectional view of aFIG. 3, taken through line 4--4, illustrating a caplet being retained byflat spring 202;

FIG. 5 is an enlarged detail of a transverse cross-sectional view of analternative holding means embodiment illustrating a spring retentionmeans 200;

FIG. 6 is an enlarged top view of an uncoated caplet;

FIG. 7 is an enlarged detail of a transverse view of the caplet of FIG.6;

FIGS. 8a-d are enlarged details of transverse views of capletsillustrating various coating patterns;

FIG. 9 is an enlarged longitudinal view of an alternative shape for anuncoated caplet;

FIG. 10 is an enlarged detail of a transverse view of the caplet of FIG.9;

FIGS. 11(a) and (b) are enlarged details of the longitudinalcross-section views of an alternative holding means embodiment showinghow the ends of the caplets are held;

FIG. 12 is a partial, transverse, cross-sectional view of the preferredfeeder device of this invention prior to the insertion of the preferredcaplet medicament into its holding means;

FIG. 13 is an enlarged, cross-sectional view of the insertion means ofthe feeder means in FIG. 12, illustrating a full caplet being disposedwithin the loading chamber;

FIG. 14 illustrates the insertion means of FIG. 13, showing how thecaplet is disposed into the guide bar using the plunger;

FIG. 15 illustrates the insertion means of FIG. 13 after the caplet isinserted into the holding means by the advancing guide bar and plunger;

FIG. 16 illustrates the insertion means of FIG. 13, illustrating thedisplaced caplet in its holding means and the retracted position of theguide bar;

FIG. 17 illustrates the insertion means of FIG. 13 when a partial capletis disposed in the medicament channel of the guide means;

FIG. 18 illustrates the insertion means of FIG. 13, illustrating thepartial caplet disposed in the loading chamber;

FIG. 19 illustrates the insertion means of FIG. 13, illustrating how theplunger is activated to move the partial caplet out of the loadingchamber and to the mouth of the guide bar;

FIG. 20 illustrates the insertion means of FIG. 13, showing how thepartial caplet is ejected from the feeder device by the plunger as theguide bar moves toward the holding means;

FIG. 21 illustrates, in partial cross-section, another preferred holdingmeans; and

FIG. 22 illustrates a transverse end view of the holding means of FIG.21.

DETAILED DESCRIPTION OF THE INVENTION

The novel process disclosed herein comprises the steps of providing aholding means having a caplet channel defined therein and inserting afirst end of a caplet into said caplet channel while leaving the secondend of the caplet exposed. The holding means is then manipulatedrelative to a bath of gelatinous material to dip the second exposed endof each caplet into that bath. The resulting gelatinous coating on thesecond exposed end of the caplet is then permitted, and preferablycaused, to dry to form a coated end. During the drying process, thecaplet may be rotated to assist in uniformly distributing gelatin duringdrying. Once dry, the coated (second) end of the caplet is thendisplaced through the caplet channel to expose its uncoated first end. Agelatinous coating is then applied to the uncoated first end of saidcaplet. The coating applied to the first end of the caplet is thenpermitted (or preferably caused) to dry, again with rotation if desiredfor the purpose of spreading the coating evenly. In accordance with thepreferred methods, the baths of gelatinous material into which thecaplet ends are dipped, may be of different colors, to thereby create asimulated 2-piece capsule look to the finished caplets with seams alongtheir transverse axes. In a preferred embodiment, one end of the capletis double-dipped, or dipped in a more viscous gelatinous material, tocreate the appearance of overlapping capsule halves.

A substantial advantage of this process is that existing hard capsulemanufacturing equipment may be readily adapted for the purpose ofproducing coated caplet products. In the preferred apparatus of thisprocess, the conventional bars of such machines, having stainless steelcapsule-forming protuberances mounted thereon, are replaced with barshaving a plurality of cylindrical holding means mounted thereon. Eachholding means receives, retains and facilitates the transfer of anindividual caplet. The apparatus is fitted with a caplet feeder to feedcaplets into each holding means. The holding means may, for example, bea cylinder which is open at both ends and which comprises a retainingmeans, such as "O"-rings or a spring biased retainer for the purpose ofholding each caplet in position during the dipping process. The feedingmeans is preferably associated with an inserting means, which may be asimple channel and plunger assembly, for inserting a first end of eachcaplet into an appropriate holding means. The feeding means ensures thateach caplet is inserted a sufficient distance to cause the second end ofthe caplet to appropriately protrude therefrom during the upcomingdipping process. Once each bar is loaded with caplets, it then proceedsto a dip station where the gelatinous coating is applied to the exposedends of the caplets protruding therefrom, whereupon the bar is rotatedthrough a first drying means for permitting the gelatinous coating todry to form a coated second end. In a preferred apparatus, the secondgripping means also comprises substantially cylindrical holders whichare open at both ends, and which have central bores definedthere-through. In this embodiment, these second holders are axiallyaligned with the bores of the first holders, at the transfer positions,whereupon a plunger or other means is used to displace the half-coatedcaplets through and out of the "backs" of the first holds and into the"backs" of the second holders, and then through the second holders untilthe remaining uncoated ends of the caplets are exposed for subsequentdipping. The dipping and drying processes are then repeated (preferablywith a different colored gelatinous coating), whereupon a capletejection means pushes the caplets out of the second holders.

In another preferred embodiment of this method, the "fronts" of thesecond holder means are aligned with the "fronts" of the first holdermeans, whereupon the caplets are mechanically transferred from the firstto the second holders without the need for an additional alignmentdevice. In still another embodiment, a single holding means is used fordipping both ends of the caplet, whereby, after dipping the second end,the caplet is transferred through this single holding means to exposethe uncoated first end. This holder is then shifted to the secondgelatinous coating bath which preferably contains a different colorgelatin for dipping the first end of the caplet.

The subject apparatus and method may be further understood withreference to the figures. FIG. 1 illustrates, diagrammatically, thepreferred method and apparatus for dipping solid caplets into agelatinous material embodying the teachings of this invention. A holdingmeans is first provided having a caplet channel 106 defined therein,which can take any form having a cross-section sized to slidably matewith said caplet 16. The caplet 16 having a first and second end, 110and 104 of FIG. 2, is inserted using inserting means 20 into said capletchannel 106 while leaving the second end of the caplet 104 exposed.Next, a gelatinous coating, known to those in the pharmaceutical arts,is applied by first application means 28 to the exposed second end 104of the caplet. The depth to which the second end 104 can be coated isdependant upon the desired color configuration and seam requirements.The half-coated caplet is then dried using the first drying means 30 and32 which permits the gelatinous coating on the second end 104 to dry,forming a coated second end. The caplet 16 is then displaced throughsaid caplet channel 106 to expose the first end 110 preferably using agripping means illustrated in the embodiment of FIG. 1 as transfer means12, alignment means 18 and second holding means 15. The caplet 16 isthen coated with a gelatinous material on its first end 110 by secondapplication means 38 which is then dried by second drying means 34 and36. resulting in a dry caplet substantially covered in gelatin.Accordingly, this invention provides novel means for providing simpleand inexpensive modifications to existing hard capsule equipment tomanufacture simulated capsule-like medicaments. This invention teachespreferred process sequences that supplement and partially replaceotherwise standard empty gelatin capsule techniques and parameters thatare known to the art. For example, gelatin materials used for thecoatings of this invention may be any of the well known types utilizedin the art of manufacturing empty capsules and coated medicaments.

Referring again to FIG. 1, the caplet 16 is fed into inserting means 20by feeder 11. The feeder 11 can operate using mechanical or pneumaticmeans. In one embodiment, a 20-40 wide channel vibrational feeder hasbeen deemed useful. However, the most preferred feeder device isdescribed in more detail below.

In the preferred embodiment, plungers displace caplets into each of aseries of molding means spaced apart along a bar mount, shown in endcross section in FIG. 1, i.e., holding means 26. Each caplet 16 is theninserted into a first holding means 26 using plunger 20. Both the firstand second holding means 26 and 15 are preferably cylindrical, havingcaplet channels 106 having a cross-section sized to slidably mate withthe caplet 16 to permit passage of the caplet 16. However, in theembodiment of FIG. 1A, these channels, or more preferably, bores, canextend through the holding means with one cross-section sized toslidably mate with caplet and another cross-section sized to receiveonly a plunging means. This design is made possible due to the fact thatthe caplets can be transferred without displacing them through theentire length of the holding means in the method embodiment of FIG. 1A.

Included with one holding means embodiment of this invention, areretaining means for retaining the caplet at least during the firstgelatinous coating application step. As shown by the embodiments foundin FIGS. 2-5, the retaining means can comprise a plurality of recessedrubber "O"-rings 100 and 102, a flat spring 202 fixed by pin 204 andhaving its convex side facing the caplet, or a resilient spring 200. Asshown in FIG. 3 the flat spring 202 may be extended to enable externalmanipulation of the retaining means. The choice of retaining means isnot critical and any known securing or resilient device may be used.However, it is important that the retaining means provide enoughclearance to pass the gelatin coated end, yet securely hold the uncoatedend.

In a most preferred embodiment of the holding means as depicted in FIGS.21 and 22, a bored cylinder 510, or equivalent, is provided with aseries of slots 512 disposed longitudinally through its walls. Asillustrated, the cylinder 510 preferably has four diametrically opposedslots 512. Although the number can vary, a series of four slots 512provides a uniform compressive force to the caplet when a preferredrubber "O"-ring is inserted in groove 514. A flange 511 is also providedon this embodiment for mounting a plurality of such holding means to abar fixture, although other means, such as threads, could serve thispurpose adequately.

Inserting means 20 preferably comprises a plunging means having at leastan end portion 22 disposed to abut the caplet 16 to effect displacementof the caplet 16 into the bore 106 of the first holding means 26.

In a preferred embodiment, a plurality of holding means are mounted on afixture which can be transferred by the mechanical pushing means of ahard gelatin capsule assembly line. In such an embodiment, insertingmeans 20 has multiple plunging means having a plurality of end portions22 disposed to abut multiple caplets to effect displacement thereof intothe fixture. In one embodiment, 10 to 50 holding means, preferably 20 to40, and most preferably 30 holding means are attached to the fixture. Aplurality of said fixtures can be fed into a conventional hard-capsulemanufacturing assembly which can accommodate about 1500 to 1800 fixturesat a time.

The caplet coating process of FIG. 1 next applies a gelatinous coatingto the second exposed end 104 of said caplet 16. A first applicationmeans 28 is employed for this purpose. In the preferred embodiment ofthis invention, groups of 4 or more fixtures are fed into a dippingmeans and vertically lowered into a gelatinous material such as methylcellulose, calcium alginate or gelatin. The depth of the dip ispreferably cam-regulated to the desired capsule size, color scheme, and"seam" requirements. As indicated in FIG. 8a-d, the color scheme can bebifurcated as depicted by caplet coatings 304 and 306, and a seam 302 or300 can be provided by overlapping the gelatinous coatings on the firstand second ends 110 and 104.

The coatings on the first and second ends 110 and 104 of the caplet,when preferably dipped in gelatin can include plasticizer such asglycerin or sorbitol, water, preservatives, coloring agents, andopacifying agents. See Reminqton's Practice of Pharmacy, pages 1625 to1630. The preferred gelatin solution should be maintained at a uniformtemperature and a constant degree of fluidity. If the gelatin solutionvaries in viscosity, it will correspondingly decrease or increase thethickness of the coating. Acceptable gelatin compositions can containsmall amounts of methyl cellulose, polyvinyl alcohols, and denaturedgelatins to modify their solubility or produce a enteric effect. Commonsources of gelatin contemplated by this invention include animal bones,hide portions and frozen pork skin. Grades of gelatin that areappropriate for this invention include pharmaceutical grade, food grade,Type A and Type B. Although the coatings herein provided can be madefrom any of these sources or grades, those learned in the art of capsulemaking are aware that the usual practice is to use a mixture of gradesand sources as dictated by availability and cost considerations.Differences in the physical properties of finished capsules as afunction of the type of gelatin used are slight. Reference may also bemade to "The Theory and Practice of Industrial Pharmacy", by Lackman,Liberman and King (1970) pages 389-398, published by Lea and Febiger,Philadelphia, PA, said pages being hereby incorporated by reference. Ina preferred embodiment of this invention, a gelatin mixture is preparedusing 40% by weight bone (150 bloom), 20% by weight hyde (245 bloom) and40% pork skin (270 bloom). This mixture has a viscosity of 500 cp asmeasured on a Brookfield Chromatograph, at an operating temperature of130° F. Coloring can be added to the coatings to produce opaque ortransparent colors such as red, white, pink, green, reddish brown, blue,yellow and black. Colored medicaments are necessary to give a specialtyproduct a distinctive appearance. Titanium dioxide is often added to thegelatin to form white medicaments, or to make an opaque colored coating.

Still referring to FIG. 1, after coating the second end 104, thegelatinous coating is permitted to dry to form a coated second end. Itis important to the teachings of this invention that the caplet 16 ispermitted to dry without contacting other objects, thus producing ashiny, simulated capsule-like finish on the caplet. In the preferredembodiment, a group of fixtures is raised from the gelatin and elevatedto the first drying means, comprising rotating means 30 and kiln means32. Preferably, the caplets are rotated to distribute the coating on thecaplet. In a most referred apparatus, the fixtures are automaticallyrevolved after dipping to spread the gelatin more evenly over the capletends and eliminate excess accrual at the ends. See Sindl, U.S. Pat. No.1,872,190, which is herein incorporated by reference. The caplets arethen fed into a kiln drying means 32. Preferably, 5-60 fixturescontaining caplets enter the drying kiln, where they move under dryingducts. Air volume, temperature and humidity are controlled in the kilnand are set to conventional process parameters known to those in theindustry.

When the gelatinous coating on the second end 104 of the caplet is dry,it is displaced through the caplet channel 106 to expose the first end110 using a gripping means illustrated in the embodiment of FIG. 1 astransfer means 12, alignment means 18 and second holding means 15. Inone preferred embodiment, the transfer means 12 comprises an end portion14 disposed to abut said caplet to effect displacement of said capletfrom the first holding means 26 to the second holding means 15. Thecaplet is then preferably displaced through the caplet channel or bore106 of the first holding means 26, through the alignment means 18 andinto said second holding means 15 to expose the uncoated first end 110of the caplet 16.

Alternatively, as depicted in FIG. 1A, when the gelatinous coating onthe second end 104 is dry, it can be displaced through the capletchannel 106 to expose the first end 110 by transferring the caplet fromthe "front" of a first holding means to the "front" of a second holdingmeans, thus eliminating the need for alignment means 18 of FIG. 1. It isalso envisioned that a single holding means 210 like the one illustratedin FIG. 11(a) and (b) could replace the use of the two holding means 26and 15 of FIGS. 1 and 1A by providing for the displacement of the capletthrough a central bore 201. Three "O"-rings 203. 205 and 207 are shownin FIGS. 11(a) and (b) for retaining the caplet during the process ofcoating the second and first ends 104 and 110 using a single holdingmeans 210. However, other retaining means, as previously described forthe holding means 26 and 15 of FIG. 1, may also be employed for thispurpose. As illustrated, in the embodiment of FIG. 1B, by transferringbars containing a plurality of holding means 210 from the left side ofthe diagrammatic view of the process of FIG. 1 to the right side, theneed for a second holding means is eliminated.

After displacing the caplet through the caplet channel 106, theprotruding first end is ready for the application of a gelatinouscoating which is illustrated on the right side of FIG. 1. As indicatedin the above preferred embodiments, groups of 4 or more fixtures can befed into a dipping means 38 and vertically lowered into a gelatinousmaterial, preferably containing a different color dye or pigment forproviding a distinctive appearance. As indicated in FIG. 8, a seam 300or 302 can now be provided by overlapping the dried coating on thesecond end 104. Through careful selection of gelatin color schemes, theseam can exhibit a different color than the ends of the caplet, i.e.,green and yellow coatings on the ends can be overlapped to form a blueseam. The gelatinous coating on the first end is then permitted to drywithout contacting other objects, as previously described for the secondend 104. Separate rotating means 34 and kiln means 36 are illustrated inFIG. 1 for drying the coating on the first end. However, those in theart may find it convenient to use the same drying apparatus used indrying the second end 104.

Finally, the caplet may be ejected from the second holder means 15 afterthe first end 110 is dry. Removal of the coated caplet 16 can beeffected by ejection means 25 which preferably is similar in structureto inserting means and transfer means 12, in that it comprises an endportion 24 disposed to abut said caplet. Removing the caplet can beaccomplished by plunging horizontally as in FIGS. 1 and 1A or byplunging the caplet out of the holding means vertically as in FIG. lB.The ejected caplet, now coated in gelatinous material, is then ready forprinting and packaging.

Referring now to FIG. 12, the novel feeder device of this invention canbe described. The feeder device includes hopper means, preferably ahopper 408 having a decreasing cross-sectional aperture therein, forcontaining solid medicaments, such as caplets 411. The hopper 408 canalso comprise agitation means for vibrating the solid medicaments.Referring now to FIG. 12, the agitation means is depicted as motor arm417 disposed to cause vibratory motion to hopper 408 through linkage480. The hopper 408 which is preferably disposed on hopper guide shaft444 and supported by bushing 443, thereby facilitates the motion ofcaplets 411 into a guide means 404.

Also included in the preferred feeder device are insertion means fordisposing at least one of the medicaments into the holding fixture 499.Guides means are provided, having a medicament channel 404 therethroughfor directing one of the solid medicaments from the hopper 408 into theinsertion means. Finally, selection means are provided for eliminatingpartial pieces of the medicaments before these pieces can be disposedinto the holding fixture 499.

In further accordance with this invention, and particularly with respectto FIG. 12, the insertion means of the feeder device can include aloading bar housing 413 disposed at an outlet end of the medicamentchannel 404.

The insertion means may further include plunger means, depicted as loadpiston 450, slidably disposed within the loading bar housing 413 foradvancing the solid medicaments or caplets 411 into the holding fixture.The loading chamber 414 can also be incorporated into the insertionmeans by rotatably mounting it to the loading bar housing 413, toprovide a first position for receiving at least a one of saidmedicaments from the medicament channel 404, to a second positionaxially aligned with the plunger means and holding fixture 499. Moreimportantly, the insertion means can include a guide bar 420 disposedbetween the loading bar housing 413 and the holding fixture 499. Thisguide bar 420 preferably includes a bore through it for receiving atleast one of the solid medicaments and for guiding this medicament intothe holding fixture 499. Preferably, this is accomplished by anactivator means, illustrated as cam mechanism 422, for providing linearmotion to the load piston 450 and guide bar 420. More preferably, theactivator means includes means for providing relative motion between theplunger means and the guide bar 420. This relative motion capability isimportant to the operation of the selection means of this invention,however, mechanical means for accomplishing relative motion aregenerally known.

Referring again to FIG. 12, the guide means can include obstructionmeans for at least preventing a flow of the medicaments from saidmedicament channel 404 after one of the medicaments is disposed withinthe loading chamber 414. Preferably, the obstruction means has astopping rod 429 laterally disposed from the guide means. This stoppingrod 429 preferably is slidably disposed within the medicament channel404 of the guide means for engaging the medicaments. Further, accordingto the preferred embodiment, an impingement means is provided for atleast preventing the flow of solid medicaments when the obstructionmeans is removed from the medicament channel 404. Preferably, theimpingement means comprises a restriction rod 428 disposed laterallyfrom the guide means. More preferably, the restriction rod 428 isremovably disposed within the caplet channel 404 between the stoppingrod 429 and the hopper means. In order to facilitate the loading of asingle medicament at a time into the loading chamber 414, therestriction rod 428 can be disposed away from said stopping rod 429 insaid medicament channel 404, at least a distance equivalent to a longestdimension of the medicaments. As used herein, "longest dimension" referstypically to the diameter of round medicaments or the length of capletsor oval shaped medicaments. As described in FIG. 12, the restriction andstopping rods 428 and 429 can be disposed on a lever means, depicted aslever 410, for alternatively engaging the restriction and stopping rods428 and 429 with said solid medicaments.

In further accordance with this invention, a method of feeding solidmedicaments into a holding fixture for processing is provided. Themethod first provides a feeding device having hopper means forcontaining the solid medicaments and a plurality of partial piecesthereof. This device also includes insertion means for disposing thesolid medicaments and partial pieces into a holding fixture and a guidemeans having a medicament channel therethrough for directing the solidmedicaments and partial pieces from said hopper means into the insertionmeans. Also included with the device of this method are selection meansfor eliminating the partial pieces from the feeder. The selection meanspreferably comprises the simple mechanical combination of the loadpiston 450, guide bar 420 and loading bar housing 413. In accordancewith this procedure, solid medicaments and partial pieces of thesemedicaments are inserted into a hopper means whereby the solidmedicaments and solid pieces are directed into the medicament channel.The medicaments and solid pieces are then introduced into the insertionmeans, whereby they are disposed into the selection means whicheliminates the partial pieces. Finally, the insertion means is activatedto insert a plurality of the full solid medicaments into a holdingfixture. It is expected that any desired medicament portion can beselected to pass the selection means, although it is preferred thatmedicaments having a length of at least 50% of the longest dimension beaccepted.

The present invention may further be understood from the followingcaplet examples:

EXAMPLE 1

A full capsule is loaded into loading chamber 414 and pushed into guidebar 420 with the load piston 450 until approximately one half of thecaplet is inserted into guide bar 420. The preferred activator meansthen activates guide bar 420 and causes guide bar 420 to move away fromthe loading bar housing 413. At the same time, the load piston 450 moveswith the caplet and the guide bar 420 until the guide bar 420 is withinclose proximity to caplet fixture 499, whereupon load piston 450 isfurther actuated to plunge the caplet into the caplet fixture 499through guide bar 420. Once that is accomplished, the plunger isreturned back into the loading bar housing and the guide bar 420 isreturned back to a preferred position approximately flush with theloading bar housing 413. The caplet fixture 499 with its half exposedcaplet is then ready for further processing and gelatin coating.

EXAMPLE 2

A partial caplet, preferably having a length of less than about one halfa full capsule length, is disposed in loading chamber 414. Load piston450 is then actuated to slide the caplet portion to the end of loadingbar housing 413; however, no part of this caplet portion is insertedinto guide bar 420. As in the previous example, the guide bar 420 andload piston 450 are then both actuated simultaneously toward the capletfixture 499. Since the caplet portion never enters the guide bar 420,load piston 450 causes the caplet portion to fall between the loadingbar housing 413 and the guide bar 420.

In accordance with Example 2, caplets having less than one half of thetotal caplet length are removed from processing prior to being dipped inthe preferred gelatin compositions. It is expected, however, that anypredetermined medicament caplet size may be chosen for inserting intothe holding fixture.

In view of the above it is expected that a novel, simulated capsule-likemedicament can be produced. The gelatin coated medicament of thisinvention which can be produced by the above method comprises a solidcaplet having a first and a second end, wherein a first gelatinouscoating is provided on said second end, and a second gelatinous coatingis provided on said first end of the caplet. The caplet generally is atleast 2.5 times longer than it is wide, and ideally comprises acylindrical shape. The first and second gelatinous coatingssubstantially cover the caplet to form a simulated capsule-likemedicament with a seam along a transverse axis of the medicament. Aspreviously discussed, the first and second ends 110 and 104 of thecaplet can be coated with gelalinous coatings of different colors toprovide a distinctive appearance for specialty products. A preferredcolor scheme for the medicament of this invention includes a capletwhich is coated in a red and white gelatinous material. It has beendiscovered that absorption of the gelatinous coating or the moisture inthe gelatinous coating by the solid caplet may be reduced by applying aconventional precoat sealant to the caplet prior to dipping into agelatinous material. See Baker, U.S. Pat. No. 3,185,626, which is hereinincorporated by reference. Without a precoat sealant, it is possiblethat some of the gelatinous coating or moisture in the coating wouldseep into the caplet, resulting in a duller surface. The gelatinouscoatings of the previously described method are generally provided insubstantially uniform thicknesses of about 5 to 40 mils, preferablyabout 10 to 30 mils, and most preferably from 15 to 25 mils. Themedicament provided in accordance with the preferred embodiments willhave a capsule-like seam generally along a transverse axis of the capletand a length which is at least 2.5 times its width. This capsule-likemedicament also preferably uses gelatin as its gelatinous coatings. In amost preferred embodiment of the simulated capsule-like medicament ofthis invention, the second gelatinous coating partially overlaps thefirst gelatinous coating to form a capsule-like seam circumscribing themedicament about a midway point of a longitudinal axis of themedicament.

Gelatin coated caplets can be supplied in a variety of shapes and sizes,from 000, the largest size which can be swallowed, to 5, which is thesmallest. Larger sizes can also be made available for use in veterinarymedicine. FIGS. 6, 7, 9 and 10 illustrate two of the preferred shapesfor caplets. FIGS. 6 and 7, show in top and transverse viewsrespectively, an oblong caplet having a raised portion circumscribingits perimeter. FIGS. 9 and 10 illustrate in longitudinal and transverseviews another preferred embodiment having a cylindrical center portionand rounded ends having a transverse diameter slightly less than that ofthe cylindrical center portion. These novel caplet designs facilitatethe dipping method herein provided since they are easily held by theabove retaining means and can be manufactured using conventionalcompression molding equipment.

From the foregoing it can be realized that this invention provides asimulated capsule-like medicament, a method for manufacturing thismedicament, and apparatus used in the method. The advantages over theprior art are: increased tamper-resistance over hollow capsules,increased swallowability over pan-coated medicaments, variable colorscheme capability not available with pan-coated medicaments, lessexpensive operating costs and a greater perception by the consumingpublic that gelatin coated caplets are more effective. Although variousembodiments have been illustrated, this was for the purpose ofdescribing, but not limiting, the invention. Various modifications,which will become apparent to one skilled in the art, are within thescope of this invention described in the attached claims.

We claim:
 1. A feeder device for inserting solid medicaments into aholding fixture during processing, comprising:(a) hopper means forcontaining said solid medicaments and a plurality of partial piecesthereof; (b) insertion means, for disposing at least said medicamentsinto said holding fixture, comprising:(i) a loading bar housing disposedat an outlet and of a medicament channel; (ii) plunger means slidablydisposed within said loading bar housing for advancing said solidmedicaments into said holding fixture; (iii) a loading chamber rotatablymounted to said loading bar housing to provide a first position forreceiving at least a one of said medicaments from said medicamentchannel to a second position axially aligned with said plunger means andsaid holding fixture; and (iv) a guide bar disposed between said loadingbar housing and said holding fixture, said guide bar having a boretherethrough for receiving at least said one of said solid medicamentsand for guiding said medicament into said holding fixture; (c) guidemeans having said medicament channel therethrough for directing at leastsaid medicaments from said hopper means into said insertion means; and(d) selection means for eliminating said partial pieces of saidmedicaments before said pieces can be disposed into said holdingfixture.
 2. The device of claim 1 further comprising activator means forproviding linear motion to said plunger means and said guide bar.
 3. Thedevice of claim 2 wherein said activator means comprises means forproviding relative motion between said plunger means and said guide bar.4. The device of claim 3 wherein said hopper means comprises agitationmeans for vibrating said medicaments.
 5. The device of claim 4 whereinsaid hopper means comprises a hopper having a decreasing cross-sectionalaperture therein.
 6. A feeder device for inserting solid medicamentsinto a holding fixture during processing, comprising:(a) hopper meansfor containing said solid medicaments and a plurality of partial piecesthereof; (b) insertion means, for disposing at least said medicamentsinto said holding fixture, comprising:(i) a loading bar housing disposedat an outlet end of a medicament channel; (ii) plunger means slidablydisposed within said loading bar housing for advancing said solidmedicaments into said holding fixture; and (iii) a loading chamberrotatably mounted to said loading bar housing to provide a firstposition for receiving at least a one of said medicaments from saidmedicament channel to a second position axially aligned with saidplunger means and said holding fixture; (c) guide means, having saidmedicament channel therethrough for directing at least said medicamentsfrom said hopper means into said insertion means, including;(i)obstruction means for at least preventing a flow of said medicamentsfrom said medicament channel after said at least one of said medicamentsis disposed within said loading chamber, said obstruction meanscomprising a stopping rod laterally disposed from said guide means, saidstopping rod slidably disposed within said medicament channel of saidguide means for engaging said medicaments; (d) impingement means for atleast preventing said flow of said solid medicaments when saidobstruction means is removed from said medicament channel; and (e)selection means for eliminating said partial pieces of said medicamentsbefore said pieces can be disposed into said holding fixture.
 7. Thedevice of claim 6 wherein said impingement means comprises a restrictionrod disposed laterally from said guide means, said restriction rodremovably disposed within said medicament channel between said stoppingrod and said hopper means.
 8. The device of claim 7 wherein saidrestriction rod is disposed away from said stopping rod in saidmedicament channel at least a distance equivalent to a longest dimensionof said medicaments.
 9. The device of claim 8 wherein said restrictionand stopping rods are disposed on a lever means for alternativelyengaging said restriction and stopping rods with said solid medicaments.